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Safety, Tolerability and Efficacy Study of LiRIS® 400mg in Women With Interstitial Cystitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TARIS Biomedical, Inc.
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01824303
First received: March 31, 2013
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.


Condition Intervention Phase
Interstitial Cystitis
Drug: LiRIS 400 mg
Other: LiRIS Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from baseline in subject reported bladder pain on a numerical rating scale [ Time Frame: Study Days 10 through12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LiRIS 400 mg
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days
Drug: LiRIS 400 mg
LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
Placebo Comparator: LiRIS Placebo
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Other: LiRIS Placebo
LiRIS Placebo contains lactose, inactive substance.

Detailed Description:

The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400mg.

In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Blinded study:

  • Women age 18 and over
  • Diagnosed with Interstitial Cystitis as defined by protocol
  • Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
  • Able to comply with visit schedule and diary completion at home

Open-label Extension:

  • Must have completed the blinded study prior to screening for the Open-label extension

Exclusion Criteria(Blinded and Open-Label Extension):

  • Pregnant or lactating women
  • History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
  • Bladder or urethral abnormality that would prevent safe insertion of investigational product
  • Requiring medication not allowed per study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824303

Locations
United States, California
Citrus Valley Medical Research , Inc.
Glendora, California, United States, 91741
United States, Florida
Atlantic Urological Associates
Daytona Beach, Florida, United States, 32114
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
The UrogynecologyCenter, LLC
Overland Park, Kansas, United States, 66209-2002
United States, Michigan
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States, 49503
William Beaumont Hospitals
Royal Oak, Michigan, United States, 48073
United States, New York
North Shore - Long Island Jewish Heath System - Monter Cancer Center
New Hyde Park, New York, United States, 11040
Premier Medical Group of the Hudson Valley PC
Newburgh, New York, United States, 12550
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Alliance Urology Specialists, PA
Greensboro, North Carolina, United States, 27403
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Volunteer Research Group, University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Canada, British Columbia
Exdeo Clinical Research Inc.
Abbotsford, British Columbia, Canada, V2S 3N6
Canada, Ontario
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 3J7
Sponsors and Collaborators
Allergan
TARIS Biomedical, Inc.
Investigators
Principal Investigator: Curtis Nickel, MD Queen's University/Kingston General Hospital/Ontario Canada
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01824303     History of Changes
Other Study ID Numbers: TAR-100-202
Study First Received: March 31, 2013
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014